CE Marking Does Not Replace FDA Registration
This is the most common misconception among European exporters. EU regulatory compliance — CE marking, EU MDR, EU MDR for IVDs, EMA approval, EU cosmetics regulation — applies exclusively within the European market. For the U.S. market, separate FDA registration is required regardless of EU compliance status.
🏭 FDA Facility Registration
Every EU facility manufacturing FDA-regulated products for the U.S. must register with the FDA — food, devices, drugs, or cosmetics.
🏛️ U.S. Agent Required
Every EU facility must designate a U.S. Agent physically located in the United States. EU Authorised Representatives and Notified Bodies do not fulfil this role.
📜 Annual/Biannual Renewal
FDA registration must be maintained — food facilities renew every 2 years, medical devices and drugs renew annually, cosmetics annually under MoCRA.
EU's Largest FDA Exporters — Full Guides Available
Germany and Italy are the EU's largest sources of FDA-regulated U.S. imports. Both have dedicated full-length guides:
FDA Registration for Germany
Medical devices, pharmaceuticals, food & cosmetics. CE marking ≠ FDA registration. Full guide.
FDA Registration for Italy
Pasta, olive oil, cosmetics, medical devices & pharmaceuticals. EU compliance ≠ FDA. Full guide.
FDA Registration for France
France is a major exporter of food products, pharmaceuticals, medical devices, luxury cosmetics, and beverages to the United States. French companies are subject to the same FDA registration requirements as any other foreign facility — EU and ANSM regulatory approval does not substitute for FDA registration.
French wine and spirits: While wine is generally not subject to FDA food facility registration, wine containing sulfites or other additives, as well as spirits and packaged beverages, may trigger FDA registration requirements. French food manufacturers, dairy exporters, and cosmetics brands all have active FDA registration obligations.
What French exporters need:
- FDA Food Facility Registration + U.S. Agent for food & beverage manufacturers
- CDER drug registration for pharmaceutical & API companies
- CDRH establishment registration for medical device manufacturers
- MoCRA facility registration for cosmetics & fragrance brands
- CE marking does NOT substitute for any FDA requirement
FDA Registration for Spain
Spain is a significant exporter of olive oil, food products, pharmaceuticals, and medical devices to the United States. Spanish AEMPS (Agencia Española de Medicamentos y Productos Sanitarios) approval does not substitute for FDA registration — Spanish manufacturers need separate U.S. compliance.
What Spanish exporters need:
- FDA Food Facility Registration + U.S. Agent for olive oil, food & beverage manufacturers
- CDER drug registration for pharmaceutical & generic drug exporters
- CDRH device registration for medical device manufacturers
- MoCRA for cosmetics & personal care brands
FDA Registration for Netherlands
The Netherlands is Europe's largest port and a major re-export and manufacturing hub for FDA-regulated products. Dutch food manufacturers, pharmaceutical companies, and medical device firms all require FDA registration — and importantly, re-exporting products through Rotterdam or Amsterdam does not transfer FDA registration obligations to the Dutch entity unless they are the actual manufacturer.
What Dutch exporters need:
- FDA Food Facility Registration + U.S. Agent for food, dairy & ingredient manufacturers
- CDER drug registration for pharmaceutical companies
- CDRH registration for medical device & diagnostics manufacturers
- MoCRA for cosmetics manufacturers
Rotterdam re-export note: If your company in the Netherlands re-exports FDA-regulated products manufactured elsewhere in Europe, the original manufacturer must have FDA registration — not the Dutch re-exporter. However, if your Dutch facility repackages, relabels, or processes the product, you may also need your own FDA registration.
FDA Registration for Belgium
Belgium is a major pharmaceutical and biotechnology hub — home to some of the world's largest pharmaceutical manufacturers and vaccine producers. Belgian pharma and biotech companies exporting to the U.S. require FDA registration independent of EMA or Belgian FAMHP approval.
What Belgian exporters need:
- CDER drug registration + NDC Labeler Code for pharmaceutical manufacturers
- BLA (Biologics License Application) pathway for vaccine & biologics exporters
- CDRH registration for medical device manufacturers
- FDA Food Facility Registration for food & chocolate exporters
FDA Registration for Sweden
Sweden is home to major pharmaceutical companies and medical device manufacturers exporting to the United States. Swedish Läkemedelsverket (MPA) and Swedish Medical Products Agency approvals do not substitute for FDA registration — Swedish manufacturers need separate U.S. compliance processes.
What Swedish exporters need:
- CDER drug registration for pharmaceutical companies
- CDRH registration for medical device & MedTech manufacturers
- FDA Food Facility Registration for food manufacturers
- MoCRA for cosmetics & skincare brands
FDA Registration for Poland
Poland is one of the EU's fastest-growing manufacturing economies and an increasingly significant exporter of food products, pharmaceutical ingredients, and medical devices to the United States. Polish URPL (Office for Registration of Medicinal Products) approval does not substitute for FDA registration.
What Polish exporters need:
- FDA Food Facility Registration + U.S. Agent for food & agricultural exporters
- CDER drug registration for pharmaceutical & API manufacturers
- CDRH registration for medical device manufacturers
- MoCRA for cosmetics manufacturers
All Other EU Member States
The same FDA registration rules apply equally to every EU member state — Austria, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Greece, Hungary, Ireland, Latvia, Lithuania, Luxembourg, Malta, Portugal, Romania, Slovakia, and Slovenia. EU membership provides no exemption. Every EU facility manufacturing FDA-regulated products for the U.S. market must register with the FDA and designate a U.S. Agent.
Ireland note: Ireland is a major pharmaceutical manufacturing hub — several of the world's largest drug companies have Irish manufacturing facilities. Irish pharmaceutical manufacturers must have active FDA drug establishment registration regardless of EMA approval or Irish HPRA licence status.
Regovant serves EU exporters across all member states. Whether your facility is in France, Spain, the Netherlands, Belgium, or any other EU country — Regovant handles your FDA registration, U.S. Agent designation, and Certificate of Registration from $300/year. Get a free consultation →